| Looking for, Sr Validation Specialist || Cambridge, MA at Cambridge, Massachusetts, USA |
| Email: [email protected] |
| From: Mayank, Pivotal Technologies [email protected] Reply to: [email protected] Role : Sr Validation Specialist Location : Cambridge, MA. Need to be able to go to Cambridge, MA, once and a while when needed. Visa : No H1 Pharma Client Locals for now Knowledge and experience with Veeva Quality (QDocs, QMS, LMS), Regulatory (RIM) is preferred. Deep understanding of the software development life cycle and computerized system validation principles. Experience working in a GxP regulated environment, preferably in the biopharma space. IT Validation Specialist Candidate should be experienced in software development, and they should have already worked through several life cycles of validation and validation planning. This person will need Veeva experience and pharma experience too. Jaffar needs someone who is strong in business analysis and critical thinking, an expert in that field. Having experience with systems other than Veeva is a plus, as they could be quick to learn. The role will require heavy documentation, validation plans, testing plans, test scripts, and business analysis skills. Validation / Business Analyst Veeva Systems Job Description : Seeking a Validation / Business Analyst Veeva Systems based at our Cambridge site or remote. This validation/business analyst will be responsible for business analysis and validation of our Veeva based applications. Knowledge and experience with Veeva Quality (QDocs, QMS, LMS), Regulatory (RIM) is preferred. Deep understanding of the software development life cycle and computerized system validation principles. Job Requirements: Knowledge of science biology, chemistry, engineering, or related discipline is preferred, or its equivalent. Experience working in a GxP regulated environment, preferably in the biopharma space. Experience working with users from the quality, clinical, and regulatory domain Knowledge and Skills: Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints. Comprehensive understanding of the Software Development Life Cycle, GAMP 5 and regulatory agency requirements. Knowledge in following areas: Project management User requirements analysis Data management and software configuration/administration Software validation testing and documentation Incident or issue management Periodic reviews and release management support Preferred domain knowledge: Domain knowledge of Quality, Clinical, and Regulatory processes Veeva Systems Experience which includes Veeva Quality and Regulatory Vault. perform change management activities in support of system enhancements and user requirements design solutions and manage configuration configure and manage integrations to Vault platform participate in the development of solutions and manage project/change timelines troubleshoot user issues author validation deliverables author Standard Operating Procedures and Work Instructions provide user trainings provide technical solutions to requirements that encompass best practice, efficiency and global considerations Strong ability to comprehend complex problems and apply knowledge to propose potential solutions. Analytical skills to be able to understand the needs of customers and work out priorities. Strong written and oral communication skills as well as organizational skills. Demonstrated ability to work effectively under established guidelines and instructions. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Major Duties and Responsibilities: Provides application validation support, documentation, training, and troubleshooting of Veeva systems that includes quality, clinical, regulatory systems which includes Veeva Quality (QDocs, QMS, LMS), and Regulatory (RIM). Communicates issues, technical failures, and projects status updates to direct manager. Review and implement change controls associated with these applications Perform project management activities in support of business process improvements. Thanks & Regards, Mayank Mer Technical Recruiter Keywords: information technology golang Massachusetts |
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| Wed Sep 06 20:55:00 UTC 2023 |